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Clinical Trials associated with RSV A2 vaccine(NIAID)Challenge Infection of Healthy Adult Volunteers With RSV A2
Background:
One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Researchers want to study RSV infection in a safe, controlled setting in healthy adults to help develop new treatments.
Objective:
To test the safety of a high dose of RSV A2 by spraying the virus into the nose, and studying how the body responds.
Eligibility:
Healthy adults ages 18-50
Design:
Participants will be screened during 2 screening visits with:
Medical interview
Physical exam
Blood and nasal samples
Chest X-ray (chest radiograph)
Participants will have a heart test. Sticky patches on the body will detect heart electrical activity.
Pulmonary function test (PFT). They will blow into a machine to measure airflow.
Urine tests for pregnancy or drug use.
Participants will be admitted to the hospital before they get RSV A2.
Participants will get a single dose of RSV A2 as two sprays, one into each nostril.
Participants will stay in the hospital under isolation for as long as it takes the body to clear RSV A2 from nasal fluids. This can take as long as 14 days or more.
Participants cannot take any cold medicine to try to feel better.
Every day, participants will:
Answer questions about their symptoms
Have nasal washes and/or nasal swabs collected
Have a physical exam
Participants will have blood drawn most days.
After discharge, participants will keep a health diary.
Participants will have 2 follow-up visits at 1 month and 2 months after receiving the RSV A2 dose. A history and physical examination, a blood draw, and nasal wash and swab will be performed.
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